Tobacco Use in Opioid Agonist Treated Pregnant Women

Nicotine Dependence Clinical Trial

— ROSE  

Official title:

Tobacco Use in Opioid Agonist Treated Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497068
• Other study ID #: R01DA012403
• Secondary ID: R01DA012403DPMCD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: March 1, 2013
• Start date: January 2005
• Est. completion date: June 2010

Study information

• Verified date: March 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Confirmed pregnancy

• Treatment entry at or before 31 weeks EGA

• Expected to enter drug-free outpatient modality at CAP

• Placed on methadone pharmacotherapy

• Nicotine dependent

• Sufficient literacy and understanding for assessment procedures

• Expected availability for study duration (e.g., complete inpatient stay)

• Able and willing to provide informed consent

• At least 18 years of age

• Confirmed smoker of 10 or more cigarettes

Exclusion Criteria:

• Not pregnant

• EGA of 32 weeks or greater

• 17 years of age or younger

• Undergoing detoxification (non-methadone treatment)

• Unable to provide informed consent

• Currently receiving nicotine replacement products (NRT)

• Current diagnosis of alcohol or benzodiazepine dependence

• Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Behavioral:
• tobacco abstinent contingent
Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
• non-contingent
Participants receive vouchers regardless of tobacco use status
• control
this group receives no vouchers

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score		from treatment entry until 6 weeks post-partum	No
Secondary	tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters		from treatment entry to 6 weeks posrt-partum	No